Keeping pace with the ever-changing life sciences industry, Morrison Foerster stays on top of the trends and political, legal, and economic drivers to support striking the balance between innovative discovery and purposeful business planning to assure our clients continued success. MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.Learn more about our <a href="https://www.mofo.com/capabilities/life-sciences-healthcare" target="_self">Life Sciences practice</a>.<h2 dir="ltr">ABOUT MORRISON FOERSTER</h2>Morrison Foerster is a leading global law firm that transforms complexity into advantage for its clients. Our clients include some of the largest financial institutions, banks, consulting and accounting firms, and Fortune 100, technology, and life sciences companies. Highlighting the firm’s commitment to client service, leadership in market-changing deals and impact litigation, and values-based culture, Morrison Foerster has been repeatedly recognized as one of the top 10 firms on The American Lawyer’s A-List. Year after year, the firm receives significant recognition from Chambers and The Legal 500 across their various guides, including Global, USA, Asia‑Pacific, Europe, UK, Latin America, and FinTech Legal. Our lawyers passionately care about delivering legal excellence while living our values. Morrison Foerster has a long-standing commitment to creating a culture that respects and celebrates differences, while providing an inclusive environment. The firm has achieved Mansfield Certification Plus since 2018 as a result of successfully reaching at least 30 percent women, communities of color, and LGBTQ+ lawyer representation in a notable number of current leadership roles and committees. The firm also has a long history of commitment to the community and society through providing pro bono legal services, including litigating for civil rights and civil liberties, improving public education and fostering the wellbeing of children, advocating for veterans, promoting international human rights, enforcing the right to asylum, and safeguarding the environment.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants. She represents clients ranging from large international pharmaceutical companies to midsized companies, startups, and universities.Meghan has filed numerous Patent Term Extension applications to secure additional term for her clients’ patents, which cover FDA-approved products. In addition, Meghan has extensive experience addressing complex obviousness-double patenting and subject matter eligibility issues impacting her clients’ patent portfolios. Meghan also represents clients in both investor-side and target-side due diligence, in deals from seed funding to initial public offerings.Prior to law school, Meghan attended graduate school at the University of California, Los Angeles, where she received a Ph.D. in biological chemistry based on her work on protein-protein and protein-DNA interactions at a molecular level. Meghan is the author of several scientific publications and has presented her research at international conferences.Meghan received her J.D. from the University of Southern California Law School and spent a year as a visiting student at Santa Clara University, where she focused on intellectual property.

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Morrison Foerster's patent prosecution and patent strategy team is highly qualified with more than 100 advanced degrees and multilingual capabilities.

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Dr. Meghan Poon counsels clients on patent preparation and prosecution, portfolio strategy, and IP due diligence in the areas of biotechnology and biologics. She has significant experience in diverse technologies including antibodies, cell therapies, gene therapies, diagnostics, and gene-edited plants.

Meghan Poon

Wolfgang advises clients on contentious and non-contentious matters involving their most valuable intellectual property assets in life sciences, digital, and high-tech industries.His subjects of focus include research and development collaborations, complex licensing agreements, and other technology transactions, as well as know-how protection strategies, and employee invention law. He also has substantial experience in litigating patents, trademarks, and other intellectual property assets, often in a multijurisdictional context. In addition, Wolfgang and his team frequently clear trademarks and ad campaigns and prosecute trademark applications.Wolfgang is co-editor of our <a href="https://lifesciences.mofo.com/" dir="ltr" target="_blank">MoFo Life Sciences Blog</a>.Wolfgang is a partner of Morrison Foerster based in our German office in Berlin.<h4 dir="ltr">Representative Transactional Matters</h4><ul dir="ltr"><li>U.S.-based BioTech fund on various research collaborations and other transactions with German start-ups or research institutions.</li><li>Negotiate multimillion-euro strategic partnership between two AgTech leaders concerning the development and commercialization of pest-resistant transgenic traits.</li><li>Craft global multi-million collaboration regarding AI-powered robotic MaaS.</li><li>UK-based digital health company on product roll-out of RPM applications in Germany; coordinate international expansion.</li><li>Advise numerous German start-ups on their U.S. expansion.</li><li>Draft diverse global patent and know-how license agreements in the areas of AgTech and life sciences—including gene licensing and licensing of genome editing technologies (e.g., CRISPR)—and medical devices; draft correlating supply and distribution agreements.</li><li>Structure IP rights in connection with joint ventures and other M&A transactions, including the carve-out of a patent-heavy semiconductor business comprising nine jurisdictions into a German–U.S. joint venture.</li><li dir="ltr">Advise on government-funded, multi-partner R&D projects and/or R&D projects with academic institutions, as well as on employee invention law.</li></ul><h4 dir="ltr">Representative Contentious IP Matters</h4><ul dir="ltr"><li>Lead counsel in an international dispute between software companies on rights and obligations following termination of a multi-million licensing and distribution arrangement; coordinate local counsel.</li><li>Defend Japanese chip manufacturer in high-profile SEP-litigation; advise on global settlement arrangement.</li><li>Represent leading internet retailer in patent infringement and concurrent invalidity proceedings in the context of a multijurisdictional dispute concerning touch-screen technology.</li><li>Represent diverse pharmaceutical and life sciences companies in national and cross-border patent infringement proceedings and other technology-related disputes, including preliminary injunctions as well as pre‑trial discovery and inspection proceedings, concerning, inter alia, drug-coating technologies, toner cartridges, medicinal gases, transgenic plants, and vaccines.</li><li dir="ltr">Conduct trademark, copyright, and false advertising litigation, including, most notably, a high-profile trademark litigation for a German bank, and a nine-country cross-border trademark litigation involving a famous pharmaceutical brand.</li></ul>

Dr. Wolfgang Schönig berät Mandanten zum Schutz des geistigen Eigentums sowohl in streitigen als auch nichtstreitigen Angelegenheiten, mit einem besonderen Fokus auf die IP-rechtliche Beratung von Unternehmen aus den Bereichen Life Sciences, Digitalwirtschaft und High-Tech.Zu seinen Beratungsschwerpunkten gehören Forschungs- und Entwicklungskooperationen, komplexe Lizenzvertragsgestaltungen und andereTechnologie-Transaktionen, sowie Know-how-Schutz-Strategien und das Arbeitnehmererfinderrecht. Er verfügt zudem über umfangreiche Prozesserfahrung zur Durchsetzung von Patenten, Marken- und anderen IP-Rechten, häufig auch in einem grenzüberschreitenden Kontext. Darüber hinaus bewertet Dr. Wolfgang Schönig zusammen mit seinem Team regelmäßig die Rechtskonformität von Werbekampagnen, prüft die Verfügbarkeit von Marken und entwickelt entsprechende Anmeldestrategien.Dr. Wolfgang Schönig ist Co-Editor des Life Sciences Blogs von Morrison Foerster.Er hat seinen Doktortitel an der Heinrich-Heine-Universität Düsseldorf und seinen LL.M. an der Fordham School of Law in New York erworben, jeweils mit Schwerpunkt im gewerblichen Rechtsschutz. Seinen MBA-Abschluss erhielt er von der European University in Barcelona.Dr. Wolfgang Schönig ist Partner des deutschen Büros von Morrison Foerster in Berlin.<h4 dir="ltr">Repräsentative Transaktionen</h4><ul><li dir="ltr">BioTech-Fonds mit Sitz in den USA bei verschiedenen Forschungskooperationen und anderen Transaktionen mit deutschen Start-ups oder Forschungseinrichtungen</li><li dir="ltr">Verhandlung einer hochvolumigen strategischen Partnerschaft zwischen zwei Technologieführern im Bereich Crop Science betreffend der Entwicklung und Kommerzialisierung von bestimmten Resistenzen</li><li dir="ltr">Gestaltung einer globalen Multi-Millionen-Zusammenarbeit für KI-gestützte Roboter</li><li dir="ltr">Ein in Großbritannien ansässiges Unternehmen für digitale Gesundheit bei der Markteinführung von RPM-Anwendungen in Deutschland; Koordination der internationalen Expansion</li><li dir="ltr">Beratung zahlreicher deutscher Start-ups bei deren US-Expansion</li><li dir="ltr">Strukturierung und Verhandlung diverser Patent- und Know-How-Lizenzen in den Bereichen Ag Tech und Life Sciences – einschließlich Fragen zu genome editing wie CRISPR-Medizingeräte, sowie Gestaltung von Softwarelizenzverträgen und Erstellung korrespondierender Liefer- und Vertriebsvereinbarungen</li><li dir="ltr">Strukturierung von IP-Rechten im Zusammenhang mit Joint Ventures und anderen M&A-Transaktionen, darunter die Koordination eines neun Länder umfassenden IP Carve-Outs im Rahmen eines Halbleiter-JVs</li><li dir="ltr">Beratung zu staatlich geförderten Multi-Partner F&E-Projekten und/oder F&E-Projekten mit akademischen Einrichtungen sowie zum Arbeitnehmererfindungsrecht</li></ul><h4 dir="ltr">Repräsentative IP-Streitigkeiten</h4><ul><li dir="ltr">Lead Counsel in einem internationalen Rechtsstreit zwischen Softwareunternehmen über Rechte und Pflichten nach Beendigung einer millionenschweren Lizenz- und Vertriebsvereinbarung; Koordinierung der lokalen Anwälte</li><li dir="ltr">Verteidigung eines japanischen Chipherstellers in einem prominenten Streitfall bezüglich Standardessentieller Patente (SEP); Beratung zu einer globalen Vergleichsregelung</li><li dir="ltr">Verteidigung einer führenden Internetplattform gegen Ansprüche eines Patenttrolls wegen vermeintlicher Verletzung von Patent bezüglich Touchscreen-Technologie sowie korrespondierende US-Streitigkeiten</li><li dir="ltr">Vertretung von Pharma- und Life Science-Unternehmen in nationalen und grenzüberschreitenden Patentverletzungsverfahren und anderen technologiebezogenen Streitigkeiten, einschließlich einstweiliger Verfügungsverfahren und vorprozessualer Beweissicherungs- und Besichtigungsverfahren, unter anderem in Bezug auf Arzneimittelbeschichtungstechnologien, Tonerkartuschen, medizinische Gase, transgene Pflanzen und Impfstoffe</li></ul>

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Wolfgang Schönig is a partner of Morrison Foerster (International) LLP based in our German office in Berlin. His practice specialty is advising on IP aspects relative to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. Wolfgang is specialized in research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig focuses his practice on IP aspects relative to transactions in the digital, telecoms, high tech, life sciences, and pharmaceuticals industry, as well as legal representation in IP disputes.

Wolfgang Schönig advises clients on IP aspects relating to transactions in, among others, the life sciences, AgTech and pharmaceuticals industry, as well as legal representation in IP disputes. His additional focus areas include research and development collaborations, complex licensing agreements, technology acquisitions, know-how protection strategies, and employee invention law.

Wolfgang Schönig

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Update 5/1/2023: FDA is reopening the comment period on the draft guidance published February 23, 2023 (88 FR 11449); the new deadline for comments is July 31, 2023.In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,” he was adding perhaps the most colorful volley in a long-simmering debate about how the Food and Drug Administration (FDA) should regulate the labeling of plant-based milk alternative (PBMA) products. In February 2023, nearly five years later, FDA finally announced <a href="https://www.fda.gov/media/165420/download" target="_blank">draft guidance</a> relating to the naming and voluntary nutrient statements of PBMA products. [1]This new draft guidance is meant to address criticism from both sides of industry about the lack of clarity from FDA regarding the labeling of PBMAs. FDA’s draft guidance was informed by a September 2018 Request for Information on plant-based dairy product labeling that elicited over 13,000 public comments, as well as research demonstrating that, while most consumers understand PBMAs do not contain milk, they are generally less informed about the nutritional differences between milk and its plant-based alternatives.The draft guidance proposed clarifications on several issues that have been the subject of substantial industry debate. There is no “standard of identity” for plant-based milk alternatives in federal law, so plant-based milks must bear the common or usual name of the food. The draft guidance acknowledges that, for many plant-based milks, the common or usual name of the product includes the word “milk.” If finalized, the draft guidance would clarify that, while a standard of identity has been established for milk, that standard of identity does not preclude another food from using “milk” in the label. However, the use must not be misleading, and FDA proposed several recommendations to ensure plant-based milk product labels are not misleading, including the following:<ul><li>PBMAs that include “milk” in the product name should include a qualifying word naming the plant source of the product (e.g., “soy milk”). When multiple plant sources are used, the guidance recommends that both sources be used in the name or the statement of identity, with the most predominant source included first (e.g., “walnut and cashew milk” or “soy and nut milk blend”).</li><li>Names that qualify the terms “beverage” or “drink” with the plant source of the food would also be okay.</li><li>The name not merely should say “plant-based milk/beverage/drink,” but should identify the plant source.</li></ul>FDA’s draft guidance, if finalized, would also settle another debate among stakeholders by clarifying that PBMAs do not need to use the term “imitation” in their labeling. While the draft guidance acknowledged that some plant-based milk alternatives may meet the FDA definition for an “imitation” milk product, the guidance does not recommend labeling such products as “imitation,” and said FDA would not take action against them as being misbranded.In addition, the draft guidance recommended that products that have a different nutritional composition than milk bear what FDA called “voluntary nutrient statements,” i.e., an additional statement on the label describing how the nutrient content differs from milk. FDA based this draft recommendation on research showing that consumers may not understand the nutritional differences between PBMAs and milk, and what FDA described as “the potential public health concern of underconsumption of certain nutrients otherwise provided by milk.” FDA’s draft recommendations include the following:<ul><li>The statement should communicate clearly to consumers when a PBMA is lower in nutrients in comparison to milk. For example, a PBMA label could read “Contains lower amounts of [nutrient name(s)] than milk.”</li><li>For any nutrient listed in USDA’s Food and Nutrition Service non-dairy beverages criteria that is lower in the PBMA product, the label bears the voluntary nutrient statement.</li><li>The voluntary nutrient statement should appear on the principal display panel near and visually connected to the product, if space allows, and the draft guidance provides several visual examples of disclaimers on product containers.</li><li>PBMAs may also make truthful and not misleading statements about nutrients that are not in the nutrient criteria list or that appear in higher amounts than the nutrient criteria list. For example, a PBMA label could read “Contains 50% more calcium than milk.”</li><li>Voluntary nutrient content statements are recommended for products called “beverage” or “drink” and not just for products that use “milk” in the name.</li></ul>The draft guidance goes to great pains to call the recommended nutrient statements “voluntary,” whereas in a guidance like this FDA would typically be providing clarifications as to what statements it considers necessary to avoid FDA considering the product misbranded. FDA may be concerned about the First Amendment implications of treating these statements as required. Nonetheless, we recommend clients seek counsel before deciding not to include a voluntary nutrient statement.Moreover, while the disclosures are “voluntary,” plaintiff’s counsel is likely to be monitoring whether companies are adding them and may challenge the failure to do so through consumer protection claims. Recent litigation has focused on whether reasonable consumers would be deceived when plant-based alternative products use names commonly associated with dairy and meat products. For example, in 2018, the Ninth Circuit ruled that Blue Diamond’s almond milk products were not in violation of False Advertising Law (FAL) in part because the defendant “accurately labels and advertises its almond milk product.” Painter v. Blue Diamond Growers, 757 F. App’x 517, 518 (9th Cir. 2018). Moreover, several cases have extended First Amendment protections to plant-based alternative products that use names commonly associated with dairy or meat products. SeeTurtle Island Foods v. Strain, 594 F. Supp. 3d 692 (M.D. La. 2022) (finding no evidence that Louisiana’s plant-based labeling limitations were necessary to prevent consumer confusion, and the state failed to address why a less restrictive alternative, such as a disclaimer, would not be sufficient to advance the government interest); Ocheesee Creamery LLC v. Putnam, 851 F.3d 1228 (11th Cir. 2017) (although “a state can propose a definition for a given term, . . . it does not follow that once a state has done so, any use of the term inconsistent with the state’s preferred definition is inherently misleading,” particularly where that definition is inconsistent with common usage).The recommendations in the draft guidance are made as the PBMA industry continues to grow, with sales reaching approximately $2.4 billion in 2020 and plant source variety continuing to diversify the marketplace. FDA is still soliciting and reviewing comments on the guidance, and its recommendations will not represent FDA’s views until finalized.We are also watching how Congress reacts to this draft guidance. FDA has already received substantial congressional interest in the guidance, including the introduction of legislation by Sens. Tammy Baldwin (D-WI), Jim Risch (R-ID), Susan Collins (R-ME), and Peter Welch (D-VT) to prevent PBMAs from using the term “milk” in their labeling. There is a long history of congressional action on behalf of food and agriculture constituencies, including actions to prevent the launch of a GE salmon product and added sugar disclosures.Morrison Foerster will continue to monitor the FDA’s guidance on PBMAs. Our regulatory and class action litigation teams work seamlessly to advise clients on product labeling and advertising decisions.Annel Becerra Rodriguez, an associate in our San Francisco office, contributed to the writing of this post.[1] The draft guidance applies only to alternative milk products and not other plant-based dairy alternatives such as cheese, yogurt, or kefir alternatives.

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Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid DeCoursey Bondoc

Brigid is a food, drug, and medical device lawyer who counsels life sciences companies on a wide range of U.S. Food & Drug Administration pre- and post-market regulatory issues.

Brigid Bondoc

In re Lumber Liquidators Chinese Laminate Litigation

Maxus Energy Corporation

In re Hydroxycut Personal Injury and Class Action Litigation

Los Angeles World Airport (LAWA)

Environmental Law Foundation v. Beech-Nut Nutrition Corp., et al

Fitbit Force Recall 

People of the State of California v. The Coca-Cola Company

Seagate Technology LLC

Clif Bar, Inc.

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Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on climate-related goals and claims, hazardous substances, mass torts, and consumer product safety.

William Tarantino

Drawing on his considerable experience in environmental health, William (Bill) focuses his practice on environmental and consumer protection law, with an emphasis on hazardous substances, mass torts, and consumer product safety.

William F. Tarantino

Nature's Path Foods

Suja Juices

Unilever USA Inc.

Nature’s Path Foods and Sprouts Farmers Market

Iovate Health Sciences, International

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Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy mat

Claudia Vetesi

Claudia focuses her practice on the defense of consumer class actions and on complex commercial litigation, including unfair business competition, false advertising, product liability, and privacy matters. She is currently representing numerous consumer goods manufacturers and retailers in false advertising and mislabeling class actions.

Claudia M. Vetesi

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FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives

230327-plant-based-milk

In 2018, when former FDA Commissioner Scott Gottlieb famously commented that “an almond doesn’t lactate,” he was adding perhaps the most colorful volley in a long-simmering debate about how the Food and Drug Administration (FDA) should regulate the labeling of plant-based milk alternative (PBMA) products. In February 2023, nearly five years later, FDA finally announced draft guidance relating to the naming and voluntary nutrient statements of PBMA products.

FDA Releases Draft Guidance for Labeling of Plant-Based Milk Alternatives

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Product Liability + Class Action

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For decades, health-conscious consumers have argued about what it really means for a food to be “healthy.” Is dark chocolate “healthy”? How about breakfast cereal, coffee, or fruit gummies? At the same time, class action litigants have seized on ever-evolving and subjective definitions of “healthy,” pursuing claims against food manufacturers based on allegations that consumers were misled by a product’s marketing into believing that the product was more “healthy” than it really is.Read the <a href="https://classdismissed.mofo.com/topics/241022-water-is-in-white-bread-is-out-healthy-gets-a-new-look-in-2023" target="_blank">full blog post</a>.

Water Is in, White Bread Is Out: “Healthy” Gets a New Look in 2023

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Associate

Lena is an associate in the Litigation Department in Morrison Foerster’s San Francisco office. Lena’s practice focuses on commercial and class actions litigation, with an emphasis on false advertising, unfair competition, and antitrust. Lena regularly counsels clients in the food and beverage, dietary supplement, cosmetics, retail, and technology sectors.











Lena Gankin

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Water Is in, White Bread Is Out: “Healthy” Gets a New Look in 2023

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For decades, health-conscious consumers have argued about what it really means for a food to be “healthy.”

Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food manufacturers, alleging that their products’ front-label protein content statements violate U.S. Food and Drug Administration (FDA) regulations, and mislead consumers by overstating the amount of protein in the food products. Read the full article below. Since spring 2020, food manufacturers have been hit with a wave of protein-labeling lawsuits all making the same core allegation: that their products' front-label protein content statements violate U.S. Food and Drug Administration regulations, and mislead consumers, by overstating the amount of protein in the food products. While the plaintiffs admit that the FDA regulations are explicitly applicable to back-label claims, they allege that these same regulations do not apply to the same statements being made on front labels. The defendants argue otherwise, claiming that the plaintiffs' proffered theory would result in the illogical result of having different protein statements on the front and back labels. And indeed, the U.S. District Court for the Northern District of California, in a February ruling in Nacarino v. Kashi Co., described the applicable regulatory scheme as "convoluted."[1] That was true — until recently. Earlier this year, the FDA released new guidance clarifying labeling requirements concerning protein claims, undermining the foundation of the labeling plaintiffs' claims. And the Northern District of California has since dismissed these protein lawsuits with prejudice. These decisions highlight the dispositive impact of preemption arguments. But in two cases, plaintiffs have since appealed the district courts' orders dismissing their claims, bringing the regulatory scheme back into question. District Courts' Distaste for Protein Suits On Feb. 10, in Nacarino v. Kashi Co., Judge Vince Chhabria dismissed with prejudice the plaintiff's claims that Kashi mislabels its food products by miscalculating their protein content.[2] The Nacarino court found that Kashi's use of the nitrogen method for calculating protein is appropriate under FDA regulations, and any claims brought by individuals based on the use of this method were preempted by the Federal Food, Drug, and Cosmetic Act.[3] In making its ruling, the Nacarino court relied heavily on the FDA's newly issued guidance on its website clarifying appropriate methods for calculating front-label protein statements. Less than a week after the Nacarino decision, another court in the Northern District of California followed suit, dismissing with prejudice the allegations of the plaintiff in Chong v. Kind LLC that Kind's front-label protein claims were deceptive and unlawful.[4] In Chong, the court declined to follow its own earlier decision in what it admitted was a "nearly identical" lawsuit from 2020, Minor v. Baker Mills, which had permitted protein-labeling claims to proceed past a motion to dismiss.[5] The Chong court acknowledged that "it has now become apparent ... that Minor was incorrectly decided."[6] Referencing Nacarino, the Chong court held that the plaintiff's claims were preempted because federal regulations establish "that producers may state grams of protein even outside the Nutrition Facts panel calculated by the nitrogen method, and without adjustment for digestibility."[7] Furthermore, the court rejected plaintiff's claims based on Kind's failure to include a percentage of the daily value of protein on the back label, in violation of FDA regulations. The court found that, because they were entirely dependent on violations of the FDCA, the plaintiff's claims under California's Sherman Law were impliedly preempted under the U.S. Supreme Court's 2001 ruling in Buckman v. Plaintiffs' Legal Committee.[8] The plaintiffs in both Nacarino and Chong have since appealed the courts' decisions dismissing their claims with prejudice.[9] Opening briefs are due in June, which will provide additional insight into the plaintiffs' basis for challenging the courts' conclusions that FDA guidance on protein claims is definitive. FDA Regulations and New Guidance Under FDA regulations, food manufacturers may calculate protein content for front-label protein claims at least two different ways: (1) calculating the amino acid content of the food directly, or (2) using the nitrogen method, which requires manufacturers to multiply the nitrogen content of the food by a factor of 6.25.[10] When food manufacturers calculate the percentage daily value of protein on the product's back label, federal regulations require that the percentage be adjusted for digestibility using a "protein digestibility-corrected amino acid score."[11] Because plant-based proteins are not fully digestible by the human body, the amount of protein calculated under the nitrogen method may differ from the amount of protein as adjusted for digestibility and as used for calculating the percentage of daily value on the back label. Plaintiffs have seized on these nuances in the federal regulations to argue that front-label protein claims overstate the amount of protein by failing to account for protein digestibility. In essence, plaintiffs claim that, despite manufacturers calculating protein claims in accordance with FDA regulations for back-label protein statements, using this same calculation for front-label claims is misleading. But no requirement to calculate protein digestibility exists for front-label claims. In its Jan. 11 guidance, the FDA made it clear that, contrary to plaintiffs' claims, food manufacturers are not required to use only an amino acid content method for calculating front-label protein statements, nor are they required to adjust the front-label content claims for digestibility. Indeed, the FDA approves of the use of the nitrogen method for front-label protein claims, and does not require that manufacturers adjust protein content for digestibility when making such claims. Looking Ahead Where plaintiffs' claims rest on an interpretation of the federal regulatory scheme that the FDA recently rejected, decisions from the Northern District of California suggest that preemption arguments may present a viable defense — at least for now. As the U.S. Court of Appeals for the Ninth Circuit grapples with Chong and Nacarino, manufacturers can expect some reprieve from the barrage of these protein case filings. Even if they are named in new filings, manufacturers have additional ammunition in their pockets, and should consider and give great weight to asserting preemption arguments and requesting a stay of their proceedings. This article is for general information purposes and is not intended to be and should not be taken as legal advice. [1] <a target="_blank" href="https://advance.lexis.com/api/search?q=2022%20U.S.%20Dist.%20LEXIS%2023409&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2022%20U.S.%20Dist.%20LEXIS%2023409&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&">Nacarino v. Kashi Co. </a>, No. 21-cv-07036-VC, 2022 WL 390815, at *1 (N.D. Cal. Feb. 9, 2022). [2] Id. [3] Id. at *5. [4] <a target="_blank" href="https://advance.lexis.com/api/search?q=2022%20U.S.%20Dist.%20LEXIS%2027438&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2022%20U.S.%20Dist.%20LEXIS%2027438&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&">Chong v. Kind LLC </a>, No. 21-cv-04528-RS, 2022 WL 464149 (N.D. Cal. Feb. 15, 2022). [5] Id. at *1; <a target="_blank" href="https://advance.lexis.com/api/search?q=2020%20U.S.%20Dist.%20LEXIS%20258880&qlang=bool&origination=law360&internalOrigination=article_id%3D1480247%3Bcitation%3D2020%20U.S.%20Dist.%20LEXIS%20258880&originationDetail=headline%3DRulings%2C%20FDA%20Guidance%20May%20Help%20Food%20Cos.%20In%20Protein%20Suits&">Minor v. Baker Mills Inc. </a>, No. 20-cv-02901-RS, 2020 WL 11564643 (N.D. Cal. Nov. 12, 2020). [6] Chong, 2022 WL 464149, at *1. [7] Id. at *3. [8] Id. at *4. [9] Nacarino v. Kashi Co., No. 22-15377 (9th Cir.) (appeal filed March 14, 2022); Chong v. Kind LLC, No. 22-15368 (9th Cir.) (appeal filed March 11, 2022). [10] See 21 C.F.R. § 101.9(c)(7). [11] Id.

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RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS

RULINGS, FDA GUIDANCE MAY HELP FOOD COS. IN PROTEIN SUITS

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Originally published by Law360, Claudia Vetesi, Nicole Ozeran, and Lena Gankin authored an article discussing a wave of protein-labeling lawsuits hitting food m

Navigating FDA’s regulatory enforcement strategies is paramount to successfully marketing health and medical products for COVID‑19—especially since the pandemic has dominated FDA’s enforcement activity this year. Understanding the patterns and principles behind FDA’s efforts can provide the insight product manufacturers need to avoid FDA enforcement and let companies know what to expect if they do become the target of enforcement action. To do just that, MoFo’s product regulatory team has tracked and analyzed these enforcement efforts against COVID-19 products to bring you this year‑end guide. <a target="_blank" href="https://classdismissed.mofo.com/topics/FDAs-COVID-19-Product-Regulation-Enforcement-Roadmap.html">Read more</a> on our Class Dismissed blog